Stakeholders at FDA's public hearing on the Commissioners National Priority Voucher program urge the agency to temporarily suspend the initiative and ...
The House passes FDAs appropriations bill for fiscal year 2027 that provides $7.1 billion for the agency.
FDA issues Xspray Pharma a complete response letter for the company's NDA for Nilopki, an improved formulation of nilotinib designed to compete with N...
FDA says its breakthrough devices program has surpassed 1,280 designations since its launch, highlighting the growing use of the expedited pathway by ...
FDA approves a Lupin BLA for Ranluspec (ranibizumab-hkdz), an interchangeable biosimilar to Genentech's blockbuster eye drug Lucentis.
FDA releases a draft guidance outlining post-approval responsibilities facing manufacturers of generic drugs, highlighting requirements ranging from a...
Radiopharmaceutical drug manufacturers say they need more consistency from FDA in inspections and regulatory operations.
The U.S. Supreme Court hands a victory to Hikma Pharmaceuticals in a closely watched case testing the patent risks of FDA-approved "skinny label" gene...
